DioGenix has entered a sponsored research agreement with Fast Forward, a subsidiary of the National Multiple Sclerosis Society, to develop a novel blood test for multiple sclerosis (MS). DioGenix's current MS diagnostic, MSPrecise, uses next-generation sequencing technology to detect changes to the adaptive immune system. It accomplishes this by measuring mutations found in rearranged immunoglobulin genes in B cells isolated from cerebral spinal fluid. Under the terms of the agreement, DioGenix will receive up to $500,000 of funding from Fast Forward to determine if MSPrecise's approach also works with blood samples. If it does, it could give clinicians the ability to diagnose MS earlier and to distinguish MS from other similar immune-mediated neurological diseases.

Roche Breaks Ground on New Customer Training Center

Roche has broken ground on a new Learning and Development Center at its North American headquarters in Indianapolis. The center will host the training of more than 1,500 customers each year, and is the first element of a $300 million site transformation intended to support the company's growing diagnostics and diabetes care businesses.

CardioDx Participates in Study of Heart Disease Diagnostics

CardioDx has joined the Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE), the first large randomized trial to compare the effectiveness of anatomical versus functional noninvasive diagnostic tests for assessment of patients with suspected coronary artery disease (CAD). As a secondary goal, the trial will also evaluate the ability of CardioDx's blood-based gene expression test, Corus CAD, to predict major clinical cardiovascular events. "The findings of PROMISE also will help us determine the potential for developing a new test specifically focused on prognosis for CAD patients, which could involve the use of next generation technologies to identify expression of genes predictive of future events," said David Levison, CardioDx president and CEO. Researchers expect 10,000 patients to enroll in the study, which is sponsored by Duke University in collaboration with the National Heart Lung and Blood Institute.

NCI Funds Insight Genetics' Development of Lung Cancer Co-Diagnostics

The National Cancer Institute granted Insight Genetics two Small Business Innovation Research (SBIR) contracts that will allow Insight to continue developing lung cancer companion diagnostics. The first, a Phase II contract, will give Insight $1.5 million to further validate its Insight ALK Screen, a real-time qPCR-based test designed to identify the approximately 5–10% of lung cancer patients with oncogenic anaplastic lymphoma kinase (ALK) mutations and fusions. Screening for these mutations is essential for determining when to prescribe ALK inhibitors. The second SBIR grant, a Phase I Fast Track contract of $200,000, will fund creation of a panel test for detecting RET and ROS1 fusions along with DEPDC1 expression in non-small cell lung cancer (NSCLC). With this funding, Insight Genetics hopes to create a high-throughput diagnostic panel that could identify these biomarkers, which account for up to 9% of NSCLC cases.

Quanterix Licenses Immunoassay Technology to bioMérieux

Quanterix and bioMérieux have signed a strategic agreement granting bioMérieux worldwide exclusive rights to Quanterix's Simoa platform. Simoa is an immunoassay technology with multiplex capability that measures single molecules and is highly sensitive for proteins that traditional analog-based methods cannot detect. Using this platform, bioMérieux plans to develop a menu of tests focused on infectious diseases. Quanterix also hopes that this alliance will give the company the "flexibility to leverage Simoa technology and apply it in other commercial opportunities of interest, whether that be in biomedical research, bioterrorism, blood banking, or point-of-care diagnostics," said Paul Chapman, Quanterix president and CEO.